Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.
Althea Technologies has been producing cGMP plasmid DNA for phase I, II, and III clinical trials for almost 10 years. We apply our extensive experience in development and manufacturing to provide complete and consistent plasmid DNA manufacturing services from cell banking to commercial scale production. Althea's state-of-the-art Commercial cGMP facilities have been custom designed for optimal personnel flow, product flow, and regulatory compliance for both US and EP standards. Using our proprietary technology, we are able to produce up to kilogram plasmid DNA quantities for use in clinical and commercial products.Advantages of contracting with Althea Technologies:
Frequently updated Biologics Master File for cGMP plasmid production on file with the FDA
Full USP testing of all incoming raw materials and no animal derived products used at any point in the process (during fermentation or purification)
Licensed by the State of California Food and Drug Branch
Proprietary purification procedure specifically designed for scale up and regulatory compliance
Services Provided:
Host strain selection and optimization
cGMP Master Cell Bank and Manufacturers Working Cell Bank production and characterization
Fermentation and purification development and optimization
Product formulation and fill / finish services
Complete QC testing and Certificate of Analysis with each lot
ICH Compliant Stability studies
Highest quality plasmid DNA:
Low endotoxin
Low residual host cell DNA
Low residual RNA
Low residual solvents
Low residual protein
Highly enriched for supercoiled plasmid DNA
Althea Technologies
A leading provider of contract services to
the pharmaceutical and biotechnology industries
11040 Roselle Street | San Diego, CA 92121-1205
Toll-free 1-888-4ALTHEA
info@altheatech.com